DeFulio A, Everly JJ, Leoutsakos JMS, Umbricht A, Fingerhood M, Bigelow GE et al. Employment-based reinforcement of adherence to an FDA approved extended release formulation of naltrexone in opioid-dependent adults: a randomized controlled trial. Drug Alcohol Depend 120: 48-54

Johns Hopkins University, School of Medicine, Baltimore, MD 21224, United States.
Drug and alcohol dependence (Impact Factor: 3.42). 07/2011; 120(1-3):48-54. DOI: 10.1016/j.drugalcdep.2011.06.023
Source: PubMed


Naltrexone provides excellent opioid blockade, but its clinical utility is limited because opioid-dependent patients typically refuse it. An injectable suspension of naltrexone for extended release (XR-NTX) was recently approved by the FDA for treatment of opioid dependence. XR-NTX treatment may require concurrent behavioral intervention to maximize adherence and effectiveness, thus we sought to evaluate employment-based reinforcement as a method of improving adherence to XR-NTX in opiate dependent adults.
Opioid-dependent adults (n=38) were detoxified and inducted onto oral naltrexone, then randomly assigned to contingency or prescription conditions. Participants received up to six doses of XR-NTX at four-week intervals. All participants could earn vouchers for attendance and performance at a therapeutic workplace. Contingency participants were required to accept XR-NTX injections to access the workplace and earn vouchers. Prescription participants could earn vouchers independent of their acceptance of XR-NTX injections.
Contingency participants accepted significantly more naltrexone injections than prescription participants (87% versus 52%, p=.002), and were more likely to accept all injections (74% versus 26%, p=.004). Participants in the two conditions provided similar percentages of samples negative for opiates (72% versus 65%) and for cocaine (58% versus 54%). Opiate positivity was significantly more likely when samples were also cocaine positive, independent of naltrexone blockade (p=.002).
Long-term adherence to XR-NTX in unemployed opiate dependent adults is low under usual care conditions. Employment-based reinforcement can maintain adherence to XR-NTX. Ongoing cocaine use appears to interfere with the clinical effectiveness of XR-NTX on opiate use.

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Available from: Michael Fingerhood, Dec 25, 2013
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    • "Further development of interventions to engage out-of-treatment injection drug users in methadone treatment and promote abstinence is needed. A potential method to promote engagement in methadone treatment and drug abstinence is the therapeutic workplace (Silverman, 2004; Silverman, DeFulio, & Sigurdsson, 2012). The therapeutic workplace intervention integrates therapeutic reinforcement contingencies into an employment program. "
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    ABSTRACT: We examined the use of employment-based abstinence reinforcement in out-of-treatment injection drug users, in this secondary analysis of a previously reported trial. Participants (N = 33) could work in the therapeutic workplace, a model employment-based program for drug addiction, for 30 weeks and could earn approximately $10 per hr. During a 4-week induction, participants only had to work to earn pay. After induction, access to the workplace was contingent on enrollment in methadone treatment. After participants met the methadone contingency for 3 weeks, they had to provide opiate-negative urine samples to maintain maximum pay. After participants met those contingencies for 3 weeks, they had to provide opiate- and cocaine-negative urine samples to maintain maximum pay. The percentage of drug-negative urine samples remained stable until the abstinence reinforcement contingency for each drug was applied. The percentage of opiate- and cocaine-negative urine samples increased abruptly and significantly after the opiate- and cocaine-abstinence contingencies, respectively, were applied. These results demonstrate that the sequential administration of employment-based abstinence reinforcement can increase opiate and cocaine abstinence among out-of-treatment injection drug users.
    Full-text · Article · Dec 2014 · Journal of Applied Behavior Analysis
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    • "This specific context was chosen because financial incentives have been used to improve medication compliance (e.g. DeFulio et al., 2012; Hill & Ramachandran, 1992; Morisky et al., 2001; Pilote et al., 1996; Sorensen et al., 2007; Volpp et al., 2008), yet their impact on the processing of side-effects associated with most medicines has thus far remained unstudied. The study specifically evaluates the impact of low-value (£25) and high-value financial incentives (£1000) on i) willingness to consume a pill with side-effects, ii) the time spent viewing the pillrelated information, and iii) risk-information processing, as assessed by a) the level of perceived risk associated with consuming the pill and b) knowledge of its side-effects. "
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    ABSTRACT: The use of financial incentives for changing health-related behaviours raises concerns regarding their potential to undermine the processing of risks associated with incentivised behaviours. Uncertainty remains about the validity of such concerns. This web-based experiment assessed the impact of financial incentives on i) willingness to take a pill with side-effects; ii) the time spent viewing risk-information and iii) risk-information processing, assessed by perceived-risk of taking the pill and knowledge of its side-effects. It further assesses whether effects are moderated by limiting cognitive capacity. Two-hundred and seventy-five UK-based university staff and students were recruited online under the pretext of being screened for a fictitious drug-trial. Participants were randomised to the offer of different compensation levels for taking a fictitious pill (£0; £25; £1000) and the presence or absence of a cognitive load task (presentation of five digits for later recall). Willingness to take the pill increased with the offer of £1000 (84% vs. 67%; OR 3.66, CI 95% 1.27–10.6), but not with the offer of £25 (79% vs. 67%; OR 1.68, CI 95% 0.71–4.01). Risk-information processing was unaffected by the offer of incentives. The time spent viewing the risk-information was affected by the offer of incentives, an effect moderated by cognitive load: Without load, time increased with the value of incentives (£1000: M = 304.4sec vs. £0: M = 37.8sec, p < 0.001; £25: M = 66.6sec vs. £0: M = 37.8sec, p < 0.001). Under load, time decreased with the offer of incentives (£1000: M = 48.9sec vs. £0: M = 132.7sec, p < 0.001; £25: M = 60.9sec vs. £0: M = 132.7sec, p < 0.001), but did not differ between the two incentivised groups (p = 1.00). This study finds no evidence to suggest incentives “crowd out” risk-information processing. On the contrary, incentives appear to signal risk, an effect, however, which disappears under cognitive load. Although these findings require replication, they highlight the need to maximise cognitive capacity when presenting information about incentivised health-related behaviours.
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    • "Employment-based reinforcement holds particular promise for reinforcing adherence with oral naltrexone. First, two studies have demonstrated that employment-based reinforcement successfully reinforces adherence with extended-release naltrexone (DeFulio et al., 2012; Everly et al., 2011). Second, incorporating naltrexone administration into a workplace setting facilitates frequent monitoring of naltrexone ingestion without imposing substantial burden on the patient or the program staff. "
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    ABSTRACT: Oral naltrexone has high potential for use as a relapse prevention pharmacotherapy for opiate dependence yet suffers from notoriously poor adherence. This study evaluated whether entry to a therapeutic workplace could reinforce adherence with oral naltrexone. Opiate-dependent and cocaine-using injection drug users were detoxified, inducted onto oral naltrexone, and randomly assigned to a contingency (n = 35) or prescription (n = 32) group for a 26-week period. Contingency participants were required to ingest naltrexone under staff observation to gain access to the therapeutic workplace. Prescription participants received a take-home supply of naltrexone and could access the workplace independent of naltrexone ingestion. Primary outcome measures were percent of urine samples positive for naltrexone at 30-day assessments and negative for opiates and cocaine at 30-day assessments. Contingency participants provided significantly more urine samples that were positive for naltrexone compared with prescription participants (72% vs. 21%, p < .01); however, no effect of experimental group was observed on percent opiate-negative (71% vs. 60%, p = .19.) or cocaine-negative (56% vs. 53%, p = .82) samples in the contingency and prescription groups, respectively. Opiate-positive samples were significantly more likely to occur in conjunction with cocaine (p < .001) and when not protected by naltrexone (p < .02), independent of experimental group. Overall, these results show that contingent access to a therapeutic workplace significantly promoted adherence to oral naltrexone, and that the majority of opiate use occurred in conjunction with cocaine use, suggesting that untreated cocaine use may limit the effectiveness of oral naltrexone in promoting opiate abstinence. (PsycINFO Database Record (c) 2012 APA, all rights reserved).
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